Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, announced that the European Commission (EC) has approved Rixathon (biosimilar rituximab) for use in Europe.

Rixathon is approved for use in all indications of the reference medicine, MabThera.

Rixathon is approved for non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, as well as immunological diseases such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

The EC approval was based on a comprehensive development program generating analytical, preclinical, and clinical – including pharmacokinetic/pharmacodynamic (PK/PD) – data. The program demonstrated Rixathon matches its reference medicine in terms of safety, efficacy, and quality.

Source: Sandoz Press release